FDA applicant

Genemed, Inc.

Middlebury, CT2 decisions1994–20040 recalls

FDA records 2 decisions for Genemed, Inc. (Middlebury, CT) from 1994 to 2004: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LNS (Lithotriptor, Extracorporeal Shock-Wave…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Genemed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Genemed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Genemed, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Genemed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Genemed, Inc.

Which product codes does it file in?

What has FDA decided for it lately?